OncoMatch/Clinical Trials/NCT06522386
GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma
Is NCT06522386 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pirtobrutinib and Rituximab for mantle cell lymphoma.
Treatment: Pirtobrutinib · Rituximab · Venetoclax — Primary Objectives: To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 overexpression
cyclin D1 overexpression (e.g., positive immunohistochemistry staining)
Required: IGH t(11;14)(q13;q32) translocation
t(11;14)(q13;q32) translocation
Required: MS4A1 overexpression
MCL cells are CD20 positive (e.g., positive staining on immunohistochemistry or flow cytometry)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: MCL-directed systemic treatment
Exception: short course of corticosteroids (≤ 1 week IV or ≤ 2 weeks oral) for acute MCL-related symptoms or impending severe organ dysfunction, with 3-day washout
No prior MCL-directed systemic treatment (such as chemotherapy, immunotherapy, targeted therapy, and cellular therapy) or radiotherapy
Lab requirements
Blood counts
ANC ≥ 1000/µL without growth factor support; Platelet count ≥ 75,000/µL without transfusion support (≥ 50,000/µL if bone marrow involvement by MCL or splenomegaly due to MCL); Hemoglobin ≥ 8.0 g/dL without transfusion support; PT/INR ≤ 1.5 × ULN; aPTT/PTT ≤ 1.5 × ULN
Kidney function
Creatinine clearance > 50 mL/min using Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 × ULN, or ≤ 3 × ULN if parenchymal liver involvement by MCL; direct bilirubin ≤ 1.5 × ULN if Gilbert's syndrome or hemolysis. ALT and AST ≤ 3 × ULN, or ≤ 5 × ULN if parenchymal liver involvement by MCL.
Cardiac function
Left ventricular ejection fraction by ECHO or MUGA ≥ 50% (within 12 months prior to registration)
Meet ALL following criteria in lab values obtained ≤ 14 days prior to registration: ANC ≥ 1000/µL without growth factor support; Platelet count ≥ 75,000/µL without transfusion support (≥ 50,000/µL if there is evidence of bone marrow involvement by MCL or splenomegaly due to MCL); Hemoglobin ≥ 8.0 g/dL without transfusion support; PT/INR ≤ 1.5 × ULN; aPTT/PTT ≤ 1.5 × ULN; Total bilirubin ≤ 1.5 × ULN, or ≤ 3 × ULN if there is evidence of parenchymal liver involvement by MCL; patients with Gilbert's syndrome or hemolysis are eligible if direct bilirubin is ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN, or ≤ 5 × ULN if there is evidence of parenchymal liver involvement by MCL; Creatinine clearance > 50 mL/min using the Cockcroft-Gault formula. Left ventricular ejection fraction by ECHO or MUGA ≥ 50% (must be within 12 months prior to registration).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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